24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Sponsor
Noven Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01101841
Collaborator
(none)
570
32
2
20
17.8
0.9
Study Details
Study Description
Brief Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:
-
Moderate VMS: Sensation of heat with sweating, able to continue activity
-
Severe VMS: Sensation of heat with sweating, causing cessation of activity
The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.
Study Design
Study Type:
Interventional
Actual Enrollment
:
570 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Twenty-Four Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Sep 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brisdelle (paroxetine mesylate) Brisdelle (paroxetine mesylate) |
Drug: Brisdelle (paroxetine mesylate)
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Other Names:
|
| Placebo Comparator: Placebo capsules Sugar pill |
Drug: Placebo capsules
Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. [Week 4 and Week 12]
Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: Mean Baseline frequency of moderate to severe VMS Mean change in frequency of moderate to severe VMS from baseline to Week 4 Mean change in frequency of moderate to severe VMS from baseline to Week 12
- Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12. [Week 4 and Week 12]
Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes
Secondary Outcome Measures
- Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24. [Week 24]
Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula: Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%.
- Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median [Week 4 and Week 12]
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
- Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median [Week 4 and Week 12]
Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline.
- Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median [Week 4 and Week 12]
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12.
- Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median [Week 4 and Week 12]
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
- Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median [Week 4 and Week 12]
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.
- Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median [Week 4 and Week 12]
The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido. The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21. The total GCS score ranges from "0" to "63" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.
- Percentage of Responders [Week 4 and Week 12]
Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.
- Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) [Week 4 and Week 12]
Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6.
- Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median [Week 4 and Week 12]
The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.
- Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS) [Week 4 and Week 12]
Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes. The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question.
- Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. [Week 4 and Week 12]
Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse".
- Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression [Week 4 and Week 12]
Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12.
- Assessment of Mood [Week 4 and Week 12]
Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from "65" to "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below.
- BMI Change From Baseline (kg/m2), Median [Week 4 and Week 12]
Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Female, >40 years of age
-
Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
-
Spontaneous amenorrhea for at least 12 consecutive months
-
Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
-
Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy
Exclusion Criteria:
-
BMI ≥ 40 kg/m²
-
Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
-
History of self-injurious behavior
-
History of clinical diagnosis of depression; or treatment for depression
-
History of clinical diagnosis of borderline personality disorder
-
Use of an investigational study medication within 30 days prior to screening or during the study
-
Concurrent participation in another clinical trial or previous participation in this trial
-
Family of investigational-site staff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montgomery Women's Health Associates, PC | Montgomery | Alabama | United States | 36116 |
| 2 | East Valley Family Physicians PLC | Chandler | Arizona | United States | 85224 |
| 3 | Genesis Center For Clinical Research | San Diego | California | United States | 92103 |
| 4 | Apex Research Institute | Santa Ana | California | United States | 92705 |
| 5 | Downtown Women's Health Care | Denver | Colorado | United States | 80218 |
| 6 | Chase Medical Research, LLC | Waterbury | Connecticut | United States | 06708 |
| 7 | Visions Clinical Research | Boynton Beach | Florida | United States | 33472 |
| 8 | Meridien Research | Brooksville | Florida | United States | 34601 |
| 9 | Women's Medical Research Group, LLC | Clearwater | Florida | United States | 33759 |
| 10 | Altus Research | Lake Worth | Florida | United States | 33461 |
| 11 | Anchor Research Center | Naples | Florida | United States | 34102 |
| 12 | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | United States | 33409 |
| 13 | Soapstone Center for Clinical Research | Decatur | Georgia | United States | 30034 |
| 14 | Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | United States | 30328 |
| 15 | Women's Clinic of Lincoln, PC | Lincoln | Nebraska | United States | 68510 |
| 16 | Phoenix Ob-Gyn Associates, LLC | Moorestown | New Jersey | United States | 08057 |
| 17 | Rochester Clinical Research | Rochester | New York | United States | 14609 |
| 18 | Hawthorne Research | Greensboro | North Carolina | United States | 27408 |
| 19 | Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | United States | 27103 |
| 20 | Columbus Center for Women's Health Research | Columbus | Ohio | United States | 43213 |
| 21 | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | United States | 19046 |
| 22 | Philadelphia Clinical Research | Philadelphia | Pennsylvania | United States | 19114 |
| 23 | Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | United States | 15206 |
| 24 | SC Clinical Research Center, LLC | Columbia | South Carolina | United States | 29201 |
| 25 | Coastal Carolina Research Center | Mt. Pleasant | South Carolina | United States | 29464 |
| 26 | Chattanooga Medical Research, LLC | Chattanooga | Tennessee | United States | 37404 |
| 27 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 28 | The Woman's Hospital of Texas Clinical Research Center | Houston | Texas | United States | 77054 |
| 29 | Virginia Women's Center | Richmond | Virginia | United States | 23233 |
| 30 | National Clinical Research, Inc. | Richmond | Virginia | United States | 23294 |
| 31 | Women's Clinical Research Center | Seattle | Washington | United States | 98105 |
| 32 | North Spokane Women's Clinic Research | Spokane | Washington | United States | 99207 |
Sponsors and Collaborators
- Noven Therapeutics
Investigators
- Principal Investigator: Derrick R Havin, MD, North Spokane Women's Clinic Research, Spokane, WA 99207
- Principal Investigator: Richard E Hedrick, MD, Hawthorne Medical Research, Inc., Winston-Salem, NC 27103
- Principal Investigator: Samuel N Lederman, MD, Altus Research, Lake Worth, FL 33461
- Principal Investigator: Larry S Seidman, DO, Philadelphia Clinical Research, LLC, Philadelphia, PA 19114
- Principal Investigator: James E Tomblin, MD, Hawthorne Medical Research, Inc., Greensboro, NC 27408
- Principal Investigator: Peter A Zedler, MD, Virginia Women's Center, Richmond, VA 23233
- Principal Investigator: D S Harnsberger, MD, Chattanooga Medical Research, LLC, Chattanooga, TN 37404
- Principal Investigator: John A Hoekstra, MD, National Clinical Research, Inc., Richmond, VA 23294
- Principal Investigator: Robin Kroll, MD, Women's Clinical Research Center, Seattle, WA 98105
- Principal Investigator: Ashley Tunkle, MD, Anchor Research Center, Naples, FL 34102
- Principal Investigator: Matthew Davis, MD, Rochester Clinical Research, Rochester, NY 14609
- Principal Investigator: Donna DeSantis, MD, East Valley Family Physicians PLC, Chandler, AZ 85224
- Principal Investigator: Steven Drosman, Genesis Center For Clinical Research, San Diego, CA 92103
- Principal Investigator: Mildred Farmer, MD, Meridien Research, Brooksville, FL 34601
- Principal Investigator: Sandra Hurtado, MD, The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054
- Principal Investigator: Bruce Levine, MD, Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057
- Principal Investigator: Tyrone Malloy, MD, Soapstone Center for Clinical Research, Decatur, GA 30034
- Principal Investigator: Eric Ross, MD, Apex Research Institute, Santa Ana, CA 92705
- Principal Investigator: Cynthia Strout, MD, Coastal Carolina Research Center, Mt. Pleasant, SC 29464
- Principal Investigator: Arthur Waldbaum, MD, Downtown Women's Health Care, Denver, CO, 80218
- Principal Investigator: Edward Zbella, MD, Women's Medical Research Group, LLC, Clearwater, FL 33759
- Principal Investigator: James R Dockery, MD, Montgomery Women's Health Associates, PC, Montgomery, AL 36116
- Principal Investigator: Stephen C Blank, MD, Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328
- Principal Investigator: Keith Aqua, MD, Visions Clinical Research, Boynton Beach, FL 33472
- Principal Investigator: Saul R Berg, MD, Clinical Trials Research Services, LLC, Pittsburgh, PA 15206
- Principal Investigator: Marvin Kalafer, MD, The Clinical Trial Center, LLC, Jenkintown, PA 19046
- Principal Investigator: David J Portman, MD, Columbus Center for Women's Health Research, Columbus, Ohio 43213
- Principal Investigator: Stephen Swanson, MD, Women's Clinic of Lincoln, PC, Lincoln, NE 68510
- Principal Investigator: Joseph Soufer, MD, Chase Medical Research, LLC, Waterbury, CT 06708
- Principal Investigator: ShaH R Scott, MD, Clinical Research Associates, Inc., Nashville, TN 37203
- Principal Investigator: Mary K Neuffer, MD, SC Clinical Research Center, LLC, Columbia, SC 29201
- Principal Investigator: Ronald Ackerman, MD, Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. Epub 2004 Aug 3. Review.
- Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30.
- Kritz-Silverstein D, Goldani Von Mühlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55.
- Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. Review.
Responsible Party:
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT01101841
Other Study ID Numbers:
- N30-004
First Posted:
Apr 12, 2010
Last Update Posted:
Oct 15, 2015
Last Verified:
Oct 1, 2015
Keywords provided by Noven Therapeutics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules in subjects with moderate to severe postmenopausal vasomotor symptoms. Locations: Medical Clinics |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Experimental Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Period Title: Overall Study | ||
| STARTED | 285 | 285 |
| COMPLETED | 235 | 218 |
| NOT COMPLETED | 50 | 67 |
Baseline Characteristics
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules | Total |
|---|---|---|---|
| Arm/Group Description | Experimental Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Total of all reporting groups |
| Overall Participants | 285 | 285 | 570 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
269
94.4%
|
267
93.7%
|
536
94%
|
| >=65 years |
16
5.6%
|
18
6.3%
|
34
6%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.2
(5.47)
|
54.5
(5.74)
|
54.4
(5.60)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
285
100%
|
285
100%
|
570
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
285
100%
|
285
100%
|
570
100%
|
Outcome Measures
| Title | Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. |
|---|---|
| Description | Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: Mean Baseline frequency of moderate to severe VMS Mean change in frequency of moderate to severe VMS from baseline to Week 4 Mean change in frequency of moderate to severe VMS from baseline to Week 12 |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 284 | 284 |
| Baseline |
10.83
(3.86)
|
10.90
(3.96)
|
| Week 4 |
-4.13
(4.02)
|
-2.71
(4.31)
|
| Week 12 |
-5.31
(4.67)
|
-3.94
(5.13)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brisdelle (Paroxetine Mesylate) Capsules, Placebo Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | Week 4 frequency | |
| Method | Rank transformed ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brisdelle (Paroxetine Mesylate) Capsules, Placebo Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | Week 12 frequency | |
| Method | Rank transformed ANCOVA | |
| Comments | ||
| Title | Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24. |
|---|---|
| Description | Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula: Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline - number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%. |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 284 | 284 |
| Number [percentage of total number of subjects] |
47.54
|
36.27
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brisdelle (Paroxetine Mesylate) Capsules, Placebo Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0066 |
| Comments | Week 24 persistence of effect | |
| Method | Logit model | |
| Comments | ||
| Title | Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median |
|---|---|
| Description | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 197 | 179 |
| Week 4 |
-28.50
|
-18.0
|
| Week 12 |
-41.00
|
-27.00
|
| Title | Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median |
|---|---|
| Description | Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 255 | 241 |
| Week 4 |
-8.50
|
-6.62
|
| Week 12 |
-13.15
|
-8.67
|
| Title | Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
|---|---|
| Description | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 60 | 65 |
| Week 4 |
-22.0
|
-17.0
|
| Week 12 |
-31.50
|
-23.00
|
| Title | Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median |
|---|---|
| Description | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 187 | 173 |
| Week 4 |
-0.033
|
-0.004
|
| Week 12 |
-0.045
|
-0.00
|
| Title | Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median |
|---|---|
| Description | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 58 | 63 |
| Week 4 |
-0.039
|
-0.036
|
| Week 12 |
-0.052
|
-0.051
|
| Title | Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median |
|---|---|
| Description | The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido. The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21. The total GCS score ranges from "0" to "63" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 216 | 203 |
| Week 4 |
-3.00
|
-3.00
|
| Week 12 |
-4.00
|
-3.00
|
| Title | Percentage of Responders |
|---|---|
| Description | Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 284 | 284 |
| Week 4 |
35.56
12.5%
|
25.35
8.9%
|
| Week 12 |
49.30
17.3%
|
33.80
11.9%
|
| Title | Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) |
|---|---|
| Description | Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 281 | 281 |
| Week 4 |
35.48
|
25.27
|
| Week 12 |
46.62
|
37.72
|
| Title | Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median |
|---|---|
| Description | The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 202 | 216 |
| Week 4 |
0.00
|
0.00
|
| Week 12 |
0.00
|
0.00
|
| Title | Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS) |
|---|---|
| Description | Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes. The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 214 | 197 |
| Week 4 |
26.03
9.1%
|
30.51
10.7%
|
| Week 12 |
15.89
5.6%
|
21.32
7.5%
|
| Title | Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. |
|---|---|
| Description | Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse". |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 249 | 231 |
| Week 4 |
67.88
23.8%
|
53.58
18.8%
|
| Week 12 |
69.88
24.5%
|
59.74
21%
|
| Title | Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression |
|---|---|
| Description | Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 218 | 210 |
| Week 4 |
5.65
2%
|
2.44
0.9%
|
| Week 12 |
4.13
1.4%
|
5.24
1.8%
|
| Title | Assessment of Mood |
|---|---|
| Description | Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from "65" to "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 218 | 208 |
| Week 4 |
37.40
13.1%
|
42.39
14.9%
|
| Week 12 |
37.16
13%
|
44.23
15.5%
|
| Title | BMI Change From Baseline (kg/m2), Median |
|---|---|
| Description | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 250 | 233 |
| Week 4 |
0.00
|
0.08
|
| Week 12 |
0.15
|
0.11
|
| Title | Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12. |
|---|---|
| Description | Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. |
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules |
|---|---|---|
| Arm/Group Description | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. |
| Measure Participants | 284 | 284 |
| Baseline |
2.525
(0.30)
|
2.532
(0.32)
|
| Week 4 |
-0.092
(0.24)
|
-0.059
(0.22)
|
| Week 12 |
-0.0126
(0.31)
|
-0.066
(0.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brisdelle (Paroxetine Mesylate) Capsules, Placebo Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0368 |
| Comments | Week 4 severity | |
| Method | Rank transformed ANCOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Brisdelle (Paroxetine Mesylate) Capsules, Placebo Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0064 |
| Comments | Week 12 severity | |
| Method | Rank transformed ANCOVA | |
| Comments | ||
Adverse Events
| Time Frame | 24 Weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules | ||
| Arm/Group Description | Experimental Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio. | ||
All Cause Mortality |
||||
| Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/285 (4.6%) | 7/285 (2.5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Abdominal pain | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Dysphagia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gastrointestinal haemorrhage | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| General disorders | ||||
| Chest pain | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hepatobiliary disorders | ||||
| Biliary dyskinesia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Cholecystitis | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Infections and infestations | ||||
| Appendicitis | 2/285 (0.7%) | 2 | 0/285 (0%) | 0 |
| Sinusitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Acetabulum fracture | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Femur fracture | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Osteoarthritis | 0/285 (0%) | 0 | 1/285 (0.4%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Endometrial cancer | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Squamous cell carcinoma | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Psychiatric disorders | ||||
| Suicidal ideation | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Suicide attempt | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Brisdelle (Paroxetine Mesylate) Capsules | Placebo Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 161/285 (56.5%) | 146/285 (51.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Lymphadenitis | 1/285 (0.4%) | 2 | 0/285 (0%) | 0 |
| Cardiac disorders | ||||
| Arrhythmia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Bradycardia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Palpitations | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Ventricular dysfunction | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Dermoid cyst | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Tinnitus | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Vertigo | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Endocrine disorders | ||||
| Hypothyroidism | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Eye disorders | ||||
| Conjunctivitis | 1/285 (0.4%) | 3 | 0/285 (0%) | 0 |
| Eye allergy | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Eye irritation | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Eye pain | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Photophobia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Retinal degeneration | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Ulcerative keratitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Vision blurred | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Vitreous haemorrhage | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Abdominal distension | 2/285 (0.7%) | 2 | 2/285 (0.7%) | 3 |
| Abdominal pain | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Abdominal pain lower | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Abdominal pain upper | 2/285 (0.7%) | 3 | 0/285 (0%) | 0 |
| Colonic polyp | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Constipation | 2/285 (0.7%) | 2 | 2/285 (0.7%) | 2 |
| Diarrhoea | 6/285 (2.1%) | 6 | 9/285 (3.2%) | 10 |
| Dry mouth | 6/285 (2.1%) | 6 | 4/285 (1.4%) | 4 |
| Duodenal ulcer | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Dyspepsia | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Dysphagia | 1/285 (0.4%) | 2 | 0/285 (0%) | 0 |
| Erosive oesophagitis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Flatulence | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Gastric ulcer | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Gastrointestinal haemorrhage | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Gastrooesophageal reflux disease | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gingival bleeding | 1/285 (0.4%) | 2 | 0/285 (0%) | 0 |
| Haematemesis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Nausea | 13/285 (4.6%) | 14 | 3/285 (1.1%) | 3 |
| Oral pain | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Sensitivity of teeth | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Stomatitis | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Toothache | 1/285 (0.4%) | 1 | 3/285 (1.1%) | 3 |
| Vomiting | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| General disorders | ||||
| Chest discomfort | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Chest pain | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Cyst | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Fatigue | 12/285 (4.2%) | 12 | 7/285 (2.5%) | 7 |
| Feeling abnormal | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Feeling jittery | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gait disturbance | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Irritability | 2/285 (0.7%) | 2 | 6/285 (2.1%) | 6 |
| Malaise | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Non-cardiac chest pain | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Oedema peripheral | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Pain | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Pyrexia | 1/285 (0.4%) | 1 | 3/285 (1.1%) | 3 |
| Hepatobiliary disorders | ||||
| Biliary dyskinesia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Cholecystitis | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Cholelithiasis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gallbladder disorder | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gallbladder polyp | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Immune system disorders | ||||
| Allergy to arthropod sting | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Drug hypersensitivity | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Seasonal allergy | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Infections and infestations | ||||
| Appendicitis | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Bronchitis | 8/285 (2.8%) | 8 | 1/285 (0.4%) | 1 |
| Cellulitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Cystitis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Diverticulitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Ear infection | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Folliculitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Gastroenteritis viral | 4/285 (1.4%) | 4 | 7/285 (2.5%) | 7 |
| Gastrointestinal viral infection | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Helicobacter infection | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Herpes zoster | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hordeolum | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Impetigo | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Influenza | 9/285 (3.2%) | 10 | 7/285 (2.5%) | 7 |
| Kidney infection | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Laryngitis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Nasopharyngitis | 20/285 (7%) | 20 | 20/285 (7%) | 22 |
| Onychomycosis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Oral herpes | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Otitis media | 2/285 (0.7%) | 2 | 0/285 (0%) | 0 |
| Perineal abscess | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Peritonsillar abscess | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Pharyngitis | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Pharyngitis streptococcal | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Pneumonia | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Pyelonephritis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Respiratory tract infection | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Sinusitis | 15/285 (5.3%) | 16 | 13/285 (4.6%) | 14 |
| Sinusitis bacterial | 0/285 (0%) | 0 | 1/285 (0.4%) | 2 |
| Tooth abscess | 2/285 (0.7%) | 2 | 3/285 (1.1%) | 3 |
| Upper respiratory tract infection | 12/285 (4.2%) | 15 | 18/285 (6.3%) | 20 |
| Urinary tract infection | 4/285 (1.4%) | 4 | 3/285 (1.1%) | 3 |
| Vaginal infection | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Viral infection | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Viral upper respiratory tract infection | 2/285 (0.7%) | 2 | 0/285 (0%) | 0 |
| Vulvovaginal mycotic infection | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Acetabulum fracture | 0/285 (0%) | 0 | 1/285 (0.4%) | 2 |
| Animal bite | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Contusion | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Excoriation | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Femur fracture | 0/285 (0%) | 0 | 1/285 (0.4%) | 2 |
| Foot fracture | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hand fracture | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Joint dislocation | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Joint sprain | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Meniscus lesion | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Muscle strain | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Periorbital haematoma | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Postoperative wound complication | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Procedural pain | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Sciatic nerve injury | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Tooth fracture | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 0/285 (0%) | 0 | 3/285 (1.1%) | 3 |
| Blood alkaline phosphatase increased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Blood creatinine increased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Blood glucose abnormal | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Blood glucose increased | 3/285 (1.1%) | 3 | 3/285 (1.1%) | 3 |
| Blood lactate dehydrogenase increased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Blood pressure increased | 0/285 (0%) | 0 | 5/285 (1.8%) | 5 |
| Cardiac murmur | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Electrocardiogram QT prolonged | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Electrocardiogram abnormal | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Haematocrit decreased | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Haemoglobin decreased | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Heart rate irregular | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Hepatic enzyme increased | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Vitamin D decreased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Weight decreased | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Weight increased | 2/285 (0.7%) | 2 | 3/285 (1.1%) | 3 |
| White blood cell count increased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hypercholesterolaemia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hyperglycaemia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Increased appetite | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/285 (1.1%) | 3 | 4/285 (1.4%) | 4 |
| Arthritis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Back pain | 6/285 (2.1%) | 6 | 5/285 (1.8%) | 5 |
| Bone pain | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Fibromyalgia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Intervertebral disc degeneration | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Joint stiffness | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Joint swelling | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Lower extremity mass | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Muscle spasms | 5/285 (1.8%) | 6 | 4/285 (1.4%) | 4 |
| Muscular weakness | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Musculoskeletal chest pain | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Musculoskeletal pain | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Musculoskeletal stiffness | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Myalgia | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Neck pain | 3/285 (1.1%) | 3 | 3/285 (1.1%) | 3 |
| Osteoarthritis | 0/285 (0%) | 0 | 2/285 (0.7%) | 3 |
| Pain in extremity | 0/285 (0%) | 0 | 3/285 (1.1%) | 3 |
| Pain in jaw | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Synovial cyst | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Tendonitis | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Benign breast neoplasm | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Endometrial cancer | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Melanocytic naevus | 0/285 (0%) | 0 | 1/285 (0.4%) | 2 |
| Metastatic neoplasm | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Squamous cell carcinoma | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Thyroid neoplasm | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Nervous system disorders | ||||
| Amnesia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Autonomic nervous system imbalance | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Carpal tunnel syndrome | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Circadian rhythm sleep disorder | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Disturbance in attention | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Dizziness | 4/285 (1.4%) | 4 | 3/285 (1.1%) | 3 |
| Dysgeusia | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Headache | 12/285 (4.2%) | 12 | 8/285 (2.8%) | 11 |
| Hyperreflexia | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hypersomnia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Hypoaesthesia | 4/285 (1.4%) | 4 | 0/285 (0%) | 0 |
| Lethargy | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Memory impairment | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Migraine | 4/285 (1.4%) | 4 | 1/285 (0.4%) | 1 |
| Neuropathy peripheral | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Paraesthesia | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Serotonin syndrome | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Sinus headache | 2/285 (0.7%) | 2 | 0/285 (0%) | 0 |
| Syncope | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Tension headache | 2/285 (0.7%) | 2 | 1/285 (0.4%) | 1 |
| Tremor | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Psychiatric disorders | ||||
| Abnormal dreams | 3/285 (1.1%) | 3 | 1/285 (0.4%) | 1 |
| Agitation | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 2 |
| Anger | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Anxiety | 3/285 (1.1%) | 3 | 7/285 (2.5%) | 9 |
| Depressed mood | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Depression | 1/285 (0.4%) | 1 | 4/285 (1.4%) | 4 |
| Elevated mood | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Emotional disorder | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Initial insomnia | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Insomnia | 6/285 (2.1%) | 6 | 8/285 (2.8%) | 8 |
| Libido decreased | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Loss of libido | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Mood altered | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Mood swings | 4/285 (1.4%) | 4 | 3/285 (1.1%) | 3 |
| Nervousness | 1/285 (0.4%) | 2 | 1/285 (0.4%) | 1 |
| Nightmare | 2/285 (0.7%) | 2 | 2/285 (0.7%) | 2 |
| Panic attack | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Restlessness | 1/285 (0.4%) | 1 | 2/285 (0.7%) | 3 |
| Self esteem decreased | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Suicidal ideation | 4/285 (1.4%) | 4 | 0/285 (0%) | 0 |
| Suicide attempt | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Tearfulness | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Thinking abnormal | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Renal and urinary disorders | ||||
| Nephrolithiasis | 1/285 (0.4%) | 3 | 0/285 (0%) | 0 |
| Urinary incontinence | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Urinary retention | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Urine odour abnormal | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Reproductive system and breast disorders | ||||
| Breast haematoma | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Breast mass | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Breast tenderness | 0/285 (0%) | 0 | 1/285 (0.4%) | 3 |
| Cervical polyp | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Pelvic pain | 1/285 (0.4%) | 2 | 0/285 (0%) | 0 |
| Postmenopausal haemorrhage | 0/285 (0%) | 0 | 3/285 (1.1%) | 3 |
| Sexual dysfunction | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Vaginal haemorrhage | 3/285 (1.1%) | 4 | 2/285 (0.7%) | 2 |
| Vulvovaginal dryness | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 3/285 (1.1%) | 3 | 0/285 (0%) | 0 |
| Chronic obstructive pulmonary disease | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Cough | 3/285 (1.1%) | 3 | 2/285 (0.7%) | 2 |
| Epistaxis | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Nasal congestion | 5/285 (1.8%) | 5 | 0/285 (0%) | 0 |
| Nasal mucosal disorder | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Oropharyngeal pain | 3/285 (1.1%) | 3 | 2/285 (0.7%) | 2 |
| Pulmonary congestion | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Rhinorrhoea | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Sinus congestion | 4/285 (1.4%) | 4 | 0/285 (0%) | 0 |
| Sneezing | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Throat irritation | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Dermatitis contact | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Hyperhidrosis | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Lichen sclerosus | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Pruritus | 2/285 (0.7%) | 2 | 3/285 (1.1%) | 3 |
| Pruritus generalised | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Rash | 4/285 (1.4%) | 5 | 2/285 (0.7%) | 2 |
| Sweat gland disorder | 2/285 (0.7%) | 2 | 0/285 (0%) | 0 |
| Surgical and medical procedures | ||||
| Dental operation | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Meniscus operation | 1/285 (0.4%) | 1 | 1/285 (0.4%) | 1 |
| Sinus operation | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
| Skin neoplasm excision | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Tooth extraction | 0/285 (0%) | 0 | 2/285 (0.7%) | 2 |
| Vascular disorders | ||||
| Hot flush | 1/285 (0.4%) | 1 | 0/285 (0%) | 0 |
| Hypertension | 3/285 (1.1%) | 3 | 3/285 (1.1%) | 3 |
| Hypotension | 0/285 (0%) | 0 | 1/285 (0.4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Sailaja Bhaskar, Executive Director, Clinical Research |
|---|---|
| Organization | Noven Therapeutics, LLC |
| Phone | (212) 287-0798 |
| sbhaskar@noven.com |
Responsible Party:
Noven Therapeutics
ClinicalTrials.gov Identifier:
NCT01101841
Other Study ID Numbers:
- N30-004
First Posted:
Apr 12, 2010
Last Update Posted:
Oct 15, 2015
Last Verified:
Oct 1, 2015